FDA Product Code
FDA Product Code SCL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5570
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal | 2026-01-30 | Traditional | PDF ↗ |
| K222385 | Bifurcated Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2022-12-06 | Traditional | PDF ↗ |
| K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC | 2019-04-10 | Traditional | PDF ↗ |
| K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | Medscience Science Research Group, Inc. | 2018-03-05 | Traditional | PDF ↗ |
| K162917 | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | 2017-08-17 | Traditional | PDF ↗ |
| K032528 | BD ECLIPSE BIFURCATED NEEDLE | Becton, Dickinson & CO | 2003-09-09 | Special | PDF ↗ |
| K031630 | BIFURCATED ALLERGY SKIN TESTING NEEDLE | Precision Medical Products, Inc. | 2003-08-07 | Traditional | PDF ↗ |
| K020523 | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 | Bd | 2002-03-20 | Traditional | PDF ↗ |
| K020500 | UNIVEC BIFURCATED SLIDING SHEATH SYRINGE | Univec, Inc. | 2002-03-19 | Traditional | PDF ↗ |
| K012515 | BIFURCATED VACCINATING NEEDLE | Precision Medical Products, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K011979 | ALLERSHARP ALLERGY SKIN TESTER | Hmb Medical Concepts, Ltd. | 2001-09-14 | Traditional | PDF ↗ |
| K003195 | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC | Greer Laboratories, Inc. | 2000-12-13 | Traditional | PDF ↗ |
| K000299 | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D | Biomedex, Inc. | 2000-04-28 | Traditional | PDF ↗ |
| K982578 | QUANTI-TEST SYSTEM | Panatrex, Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K961918 | MULTI-TEST II | Lincoln Diagnostics, Inc. | 1996-08-07 | Traditional | PDF ↗ |
| K953939 | QUINTEST | Bayer Corp. | 1995-11-13 | Traditional | PDF ↗ |
| K941820 | DUOTIP-TEST | Lincoln Diagnostics, Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K922177 | DISPOSABLE MULTI-PUNCTURE APPLICATOR | Allergy Extract Co. | 1993-06-17 | Traditional | PDF ↗ |
| K890360 | GREER DERMAPIK SYSTEM | Greer Laboratories, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K882360 | DERMAPIK | Creative Scientific Equipment Corp. | 1988-08-09 | Traditional | PDF ↗ |
| K844221 | HMB ALLERGOGEN SKIN PRICK TEST NEEDLE | Aller/Guard, Inc. | 1985-02-08 | Traditional | PDF ↗ |
| K842107 | COMBO SKIN TEST READY TO USE TAPE | Combion Systems, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K833999 | COMBION SKIN TEST - FOUR PRONG | Nicholas H. Maganias | 1984-09-05 | Traditional | PDF ↗ |
| K791328 | ALLER-SCREEN SKIN TEST KIT | Aller-Screen, Inc. | 1980-05-30 | Traditional | PDF ↗ |
| K760699 | MULTI-TEST | Lincoln Laboratories, Inc. | 1976-12-30 | Traditional | PDF ↗ |
Product code SCL · Class II · General Hospital. Data: openFDA.